Beckman Coulter Lactate Assay Recalled Due to NAC Interference
Beckman Coulter is recalling Lactate Assay kits because N-acetyl cysteine (NAC) administration can cause falsely low test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential diagnostic error (falsely low results) rather than direct physical injury or death, fitting the Moderate criteria for low-risk contamination or labeling/functional issues without reported harm.
Plain-English summary
Beckman Coulter Inc. is recalling the Lactate Assay, Catalog No. OSR6X93. The recall involves 31,799 units total, with 15,841 units distributed in the United States and Puerto Rico. The product was distributed worldwide to numerous countries.
The recall is due to interference from N-acetyl cysteine (NAC), a medication used to treat acetaminophen overdose. When NAC is administered in therapeutic concentrations, it interferes with the assay, potentially leading to falsely low lactate results. This issue affects all lots of the product.
Healthcare facilities and laboratories should stop using the affected Lactate Assay kits and contact Beckman Coulter for instructions on how to proceed. The recall is limited to the specific Lactate Assay product identified in the notice.
The recalled product
- Product
- Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
- Manufacturer
- Beckman Coulter Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 4 recalled by Beckman Coulter Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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